Senior Manager Quality Control Investigations
Core
Lead and manage deviation and investigation processes for Quality Control operations, ensuring scientific rigor, compliance, and root cause analysis for laboratory events.
Role type
Senior Manager, Quality Control Investigations
Builds
Investigation outcomes, CAPA execution, and continuous improvement initiatives for QC operations
Domain
Pharmaceutical manufacturing / Quality Control / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, regulatory compliance (FDA/EMA/ICH), data integrity, laboratory systems oversight, risk assessment, training delivery
Preferred skills
Electronic quality systems (Veeva, TrackWise, SAP), laboratory informatics (LIMS)
Technologies
Veeva, TrackWise, SAP, LIMS
Responsibilities
Lead deviation and investigation process for QC operations; Serve as SME for root cause analysis and CAPA development; Ensure investigations are data-driven and scientifically rigorous; Partner with QA, Manufacturing, and Regulatory teams; Monitor and trend QC investigation data; Support internal audits and regulatory inspections; Develop training for QC personnel on investigation best practices
Seniority
Senior Manager, site-level influence
